Why do different criteria for cure yield different conclusions in comparing two treatments for bacterial vaginosis?
Author(s): Thomas KK, Sanchez S, Garcia PJ, Holmes KK Affiliation(s): University of Washington, Department of Medicine, Seattle, Washington 98104, USA. Publication date & source: 2005-09, Sex Transm Dis., 32(9):526-30. Publication type: Clinical Trial; Randomized Controlled Trial OBJECTIVE: The objective of this study was to determine why different criteria for response to treatment of bacterial vaginosis (BV) led to markedly different conclusions about treatment efficacy in a randomized trial comparing metronidazole gel versus metronidazole/nystatin ovules. STUDY: We compared the impact of two treatment regimens on individual components of Amsel and Nugent criteria at follow-up visits 14, 42, and 104 days after initiating treatment. RESULTS: Compared with gel, ovules more effectively eliminated amines, clue cells, and Gardnerella, Prevotella, or Mobiluncus morphotypes from vaginal fluid, thus achieving cure based on “usual” criteria (absence of BV by Amsel or Nugent criteria), but did